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Diss Factsheets
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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021-05-11 to 2021-07-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: “Regulation on Test Methods for Chemical Substances” Notification No. 2020-46, National Institute of Environmental Research, Republic of Korea
- Version / remarks:
- 2020-11-03
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted 2001-12-17
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- reaction mass of diethyl (E)-2-methylbut-2-enedioate, diethyl (Z)-2-methylbut-2-enedioate and diethyl 2-methylenebutanedioate
- Cas Number:
- 2245967-74-0
- Molecular formula:
- C9H14O4
- IUPAC Name:
- reaction mass of diethyl (E)-2-methylbut-2-enedioate, diethyl (Z)-2-methylbut-2-enedioate and diethyl 2-methylenebutanedioate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl:CD(SD), SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 185.3 – 201.6 g
- Fasting period before study: 16 hours
- Housing: One animal per cage in stainless wire mesh cages, 260 x 350 x 210 mm
- Diet: Ad libitum (except for 4 hours after dosing)
- Water: Ad libitum
- Acclimation period: 7 days
- Microbiological status: SPF
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 – 23.0
- Humidity (%): 57.1 – 63.5
- Air changes (per hr): 10 − 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From day 1 to day 15
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 5 mL/kg bw
- Batch No: MKCM3364
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose level for this study was selected at 2000 mg/kg bw because the toxicity of the test substance was expected to be low by referring to the toxicity of similar substances. - Doses:
- 2000 mg/kg bw (2x3 animals)
- No. of animals per sex per dose:
- 6 females at 2000 mg/kg bw (3 animals for step 1 and 3 animals for step 2)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs at 30 minutes and at 1, 2, 4 and 6 hours after dosing and once daily thereafter for 14 days. The body weight was recorded once on the day of dosing (prior to dosing), and on days 2, 4, 8 and 15.
- Necropsy of survivors performed: Yes
- Clinical signs including body weight: Clinical signs were recorded according to their type, severity, time of onset and recovery.
- Other examinations performed: Complete gross postmortem examinations. Since no gross findings were observed at necropsy, histopathological examination was not performed. - Statistics:
- Statistical analysis was not performed. Mean scores and values were determined.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- There were no deaths of animals at 2000 mg/kg bw throughout the study.
- Clinical signs:
- other: No abnormalities of clinical signs were observed in any animal at 2000 mg/kg bw throughout the study.
- Gross pathology:
- No abnormal gross findings were observed in any animal at 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance was classified as ‘Category 5 or Unclassified’ according to the GHS classification, and the median lethal dose derived was: LD50 cut off ≥ 5000 mg/kg bw.
- Executive summary:
This GLP compliant study according to OECD guideline 423 was conducted to assess the potential toxicity and to classify the test substance under the category of GHS classification following a single oral administration to 8-week-old female Sprague-Dawley rats. Two groups of three females each were utilized as follows:
Groups 1 and 2 (Steps 1 and 2): 2000 mg/kg bw of the test substance
Steps 1 − 2: A dose of 2000 mg/kg bw was administered and then, no mortality was observed (Step 1). A second dose of 2000 mg/kg bw was administered. Again, no mortality was observed (Step 2). The administration was finished at that point.
All animals were monitored for clinical signs and body weight changes during the 14-day observation period after dosing. They were subjected to a gross necropsy after euthanasia at the end of the observation period. There were no deaths of animals at 2000 mg/kg bw. No test substance-related effect was observed in clinical signs, body weight data or necropsy findings in the animals at 2000 mg/kg bw. Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance was classified as ‘Category 5 or Unclassified’ according to the GHS classification, and the median lethal dose derived was: LD50 cut off ≥ 5000 mg/kg bw.
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